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Ronco Enterprises Hk Ltd

⚠️ Moderate Risk

FEI: 3003717446 • Hong Kong • HONG KONG

FEI

FEI Number

3003717446

📍

Location

Hong Kong

🇭🇰

Country

HONG KONG
🏢

Address

Rm806 Nan Pung Centrb 264 298 Castle, , Hong Kong, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

25.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
2
Unique Violations
10/11/2002
Latest Refusal
10/11/2002
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

2352×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

3412×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
10/11/2002
86HOISPECTACLE, MAGNIFYING
235NOT IMPACT
341REGISTERED
Los Angeles District Office (LOS-DO)
10/11/2002
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Ronco Enterprises Hk Ltd's FDA import refusal history?

Ronco Enterprises Hk Ltd (FEI: 3003717446) has 2 FDA import refusal record(s) in our database, spanning from 10/11/2002 to 10/11/2002.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Ronco Enterprises Hk Ltd's FEI number is 3003717446.

What types of violations has Ronco Enterprises Hk Ltd received?

Ronco Enterprises Hk Ltd has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Ronco Enterprises Hk Ltd come from?

All FDA import refusal data for Ronco Enterprises Hk Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.